Search the KHIT Blog

Monday, September 24, 2018

The Biden Cancer Initiative

"The Biden Cancer Initiative is a response to the lack of a cohesive, comprehensive and timely approach to cancer prevention, detection, diagnosis, research, and care."

One hopes this effort will get significant, sustained, and effective traction.

Last Friday Cheryl and I attended the local Biden Cancer Summit, which was held at John Muir Hospital in Concord (where I'd had my SAVR px heart surgery 28 days prior). Local congressman (and cancer survivor) Mark DeSaulnier hosted the event, which was comprised of a panel of clinical and medical business experts, and a panel of cancer survivors, with Q&A sessions following each panel discussion.
The CEO of the Muir Health System, Cal Knight, spoke. I subsequently introduced myself to him, and gave the hospital high praise for my treatment.
Given our long and painful history as family cancer caregivers and my own 2015 experience as a cancer patient, we found it all very interesting, if not exactly news to us. Nicely done.

Joe Biden:

I need to give some thought on how best to support this effort going forward, as I heal up fully.

All lofty, laudable principles. A number of them, however, (1, 2, 4 & 5 in particular), go to chronically contentious "multi-stakeholder" policy issue areas (e.g., "data transparency / interoperability," proprietary intellectual property vs. "open source," a more just and broadly effective health care payment system, etc). I find no detail on the website at this point addressing any of these areas in any substance (beyond, arguably, tangentially, inferentially these links). There's much drill-down work to be done (say, e.g., seven BCI "White Papers" for starters) if this undertaking is to bear fruit.

apropos, see also the NIH/NCI "Cancer Moonshot."


Again, from a BCI website link:
The Biden Cancer Initiative announced 57 new commitments from the public and private sectors in response to Vice President Joe and Dr. Jill Biden’s call to find solutions that will double the rate of progress against the [sic?] cancer. These innovative programs and partnerships focus on data sharing, patient support, education, and empowerment, research, clinical trials, access to care, disparities, and prevention and early detection...
OK. "...double the rate of progress." Do we have a current baseline aggregate operational definition of the current "rate of progress?" (Or, more plausibly, stratified rates of progress? Changes in Prevalence? Incidence? Mortality rates? Median survival times? Remission rates? etc.)


Some cautionary thoughts, via STATnews:
More research on ‘dying healthy’ will also help us live healthier

…Advances in medical treatment, including cancer treatments, are increasingly unlikely to provide further significant gains in human longevity. An analysis of 71 cancer drugs consecutively approved between 2001 and 2012, for example, suggests that their overall contribution to survival was just 2.1 months; the gains attributable to personalized cancer medicine have, so far, also been minimal.

Lacking evidence that the human life span can be radically increased by new medical technologies, we believe it’s time to shift our country’s investment priorities away from medical research that aims to extend life and instead focus on the same social, cultural, and political factors that successfully prolonged life in the last century.

That means more public investment in education, transportation, and housing. That kind of investment would directly contribute to the prevention of chronic diseases such as diabetes, heart disease, and many cancers, and would do more to improve the quality of life of the population than additional medical research aimed at treating individuals with specific diseases.

Don’t get us wrong. We aren’t suggesting that we should eliminate funding for medical research to try to prevent, or even cure, diseases. Instead, we are suggesting that public funding should emphasize research on improving and sustaining quality of life rather than focusing on increasing length of life. This means giving greater priority to diseases that affect decades of people’s lives, such as arthritis, autism, macular degeneration, and Alzheimer’s disease over end-of-life diseases like extreme dementia and many cancers…
My early 90's healthcare QI Mentor, IHC's Brent James (MD, M.Stat) cautioned us "let's don't kid ourselves that we're going to QI our way out of the larger social conundrum: every patient for whom you provide the very best care and outcome today will eventually return as a much older and sicker patient."

And, now, as I've noted recently, to the myriad largely "non-clinical" socioeconomic "upstream" factors to be taken into account, we have to add in "exposomics" to the vast "Omics" disciplines.
Tangentially, does "dying healthy" have anything to do with "A Good Death?"

Stay tuned. Forefront cancer research will surely be fraught with multiple difficulties.

Click to enlarge
"Given the billions of dollars the world invests in science each year, it's surprising how few researchers study science itself. But their number is growing rapidly, driven in part by the realization that science isn't always the rigorous, objective search for knowledge it is supposed to be. Editors of medical journals, embarrassed by the quality of the papers they were publishing, began to turn the lens of science on their own profession decades ago, creating a new field now called “journalology.” More recently, psychologists have taken the lead, plagued by existential doubts after many results proved irreproducible. Other fields are following suit, and metaresearch, or research on research, is now blossoming as a scientific field of its own.

For some, studying how the sausage is made is a fascinating intellectual pursuit in itself. But other metaresearchers are driven by a desire to clean up science's act…"
Tangentially, I cannot help but be reminded of something I wrote more than 20 years ago during my late elder daughter's cancer illness:
'Arrogant, narrow-minded, greedy, and indifferent?'
Is science the enemy? To the extremist "alternative healing" advocate, the answer is a resounding 'yes'! A disturbing refrain common to much of the radical "alternative" camp is that medical science is "just another belief system," one beholden to the economic and political powers of establishment institutions that dole out the research grants and control careers, one that actively suppresses simpler healing truths in the pursuit of profit, one committed to the belittlement and ostracism of any discerning practitioner willing to venture "outside the box" of orthodox medical and scientific paradigms.
One e-mail correspondent, a participant in the internet newsgroup, vented splenetic at length recently regarding U.S. authorities' alleged hounding, arrest, and imprisonment of alternative healers. He railed that law enforcement, at the behest of the AMA/FDA Conspiracy (a.k.a. the "corrupt AMA/FDA/NCI/ACS cartel"), had made the practice of alternative medicine illegal in the U.S. Moreover, he considered the fact that medical science can only claim "cures" for approximately 10% of the roughly 10,000 classified human diseases an a priori indictment of the mainstream profession.

I know: this is akin to the U.N. Black Helicopters/One-World-Government Conspiracy stuff of the not-too-tightly-wrapped. Still, I couldn't resist-- pointing out in (no doubt futile) reply that no one came with guns drawn and cuffs at the ready the night at Brotman Rehab when "Healing Angelite Crystals" practitioners-- devotees of India's Sai Baba-- came from Topanga Canyon to hover for hours in ceremony over Sissy (to the curious and wary befuddlement of the night shift nurses); neither did Security nor the medical staff at Brotman confiscate the goopy-looking herbal tonic we brought in, an elixir prescribed for Sissy by a Chinese herbal pharmacist doing business quite openly in Chinatown near downtown L.A.; nor would SWAT teams pounce on the backyard in the Valley where we took part in evening-long Lakota Souix "healing sweat lodge" ceremonies conducted by the venerable Wallace Black Elk; and finally, Wyndie, one of Sissy's highly skilled and effective physical therapists at Brotman did not have her certification revoked for counseling my daughter on the Hindu principles of the Chakras and efficacy of aromatherapy.

Moreover, I had to respond, the fact that we can only cure 10% of known diseases implies nothing regarding the quality of mainstream medical research and practice, unless the alternatives industry can provide hard, "case-mix adjusted," scientifically valid data showing their methods to effect consistently and significantly better outcomes-- which they cannot (a dearth of peer-reviewed studies being a central characteristic of "alternative" practice). Additionally, I asked, can anyone even cite historical curative percentages from 30, 50, or perhaps 100 years ago? Indeed, even such statistics would prove problematic-- "shooting at a moving target," as it were-- in that more subtle and clinically unresponsive maladies continue to be discovered and classified while the easier to treat are dealt with more readily. And, classificatory observation is easy compared to the work and resources required to effect cures; we should expect that identification will outpace remedy. Finally, 50 years ago death certificates listing demise from "natural causes" would today likely have identifiable diseases recorded as the cause of death.

Purveyors of medical quackery should fear the hot breath and hard heel of competent authority, but I see no evidence of suppression of alternative therapy methods that are not certifiably fraudulent. All manner of "unproven" substances are sold quite openly at retail, both in the health food stores and in the national chain outlets; all that need accompany the product is the legal boilerplate disclaimer acknowledging an absence of FDA blessing, along with the inoculating phrase 'dietary supplement.'

In fairness, as I've noted before, "I am not a scientist."

"More recently, psychologists have taken the lead, plagued by existential doubts after many results proved irreproducible."
apropos, I just finished this excellent book by esteemed psychologist James Alcock.

As reviewed at Science Based Medicine:
How We Believe
James Alcock’s new book about belief is a masterpiece that explains how our minds work, how we form beliefs, and why they are so powerful. It amounts to a course in psychology and an owner’s manual for the brain.
Harriet Hall on June 26, 2018

In James Alcock’s classic 1995 article “The Belief Engine“, he said, “Our brains and nervous systems constitute a belief-generating machine, a system that evolved to assure not truth, logic, and reason, but survival.” Now he has expanded that thesis into a book, Belief: What It Means to Believe and Why Our Convictions Are So Compelling. It’s much more than a book about belief. In the Foreword, Ray Hyman says it would be an ideal textbook for a course that provides an integrated overview of all the areas of psychology. He says every psychologist and psychology student should read it. It is an outstanding achievement of scholarship; its 640 pages include over 70 pages of references. It covers everything from the latest findings in neuroscience to a catalog of many of the questionable beliefs people hold, and why they hold them…
The neuropsychology of cognition (and our chronic risks of irrationality), basically. A must-read, IMO. Add another tome to my stash going to my abiding interest in the salient aspects of the cognitive attributes (and liabilities) of "expertise" (e.g., "how doctors think").


Got onto this via a STATnews article, "There's so much health noise..."

"I’m not a cynic. I think we need to keep an open mind and look for potential benefits wherever they may be found. But in this era of twisted facts, we all could use a nudge to keep applying critical thinking skills."
Read Alcock's compelling book "Belief." I've long and deeply studied "critical thinking," both as an undergrad and in grad school, and even thereafter got to teach it as an adjunct, but Alcock's work adds a much larger dimension. Were I teaching today, "Belief" would be a required text.

See also

Joe Schwarcz PhD - Director

I've just finished watching the Netflix "Detox" episode of Timothy Caulfield's documentary. A must-see.


Biden Summit discussions were replete with allusions to the imperative of "early detection." As reported in (firewalled) Science Magazine:
"CancerSEEK, and ye shall find?"

Most cancers are detected when they cause symptoms that lead to medical evaluation. Unfortunately, in too many cases this results in diagnosis of cancers that are locally invasive or already metastatic and hence no longer curable with surgical resection or radiation treatment. Medical therapies, which might be curative in the setting of minimal tumor burden, typically provide more limited benefit in more advanced cancers, given the emergence of drug resistance (1). On page 926 of this issue, Cohen et al. (2) describe a strategy for early cancer detection, CancerSEEK, aimed at screening for multiple different cancers within the general population. This study challenges current assumptions in the field of blood-based biomarkers and sets the stage for the next generation of cancer screening initiatives.

Given the potential curative advantage of earlier diagnosis and treatment, why have so many cancer screening approaches failed? In the past, efforts at screening healthy populations for cancer have relied on tests that were insufficiently specific. For example, most men with rising serum prostate-specific antigen (PSA) do not have prostate cancer but instead have benign prostatic enlargement. However, where accurate tests exist, there have been dramatic improvements in cancer outcomes (3). For example, advanced cervical cancer has virtually disappeared in countries where Pap screening is the standard of care; although less reliable, mammography and screening colonoscopy are recommended for early detection of breast and colon cancers in individuals above ages 40 to 45 and 50, respectively, and screening heavy smokers by use of low-dose chest computed tomography (CT) scans reduces deaths from lung cancer (4). However, these tests are imperfect, and cost-effectiveness for broad deployment remains a challenge, particularly because a multitude of false-positive test results may lead to extensive diagnostic evaluations and unnecessary medical interventions. Unfortunately, for the majority of cancers no effective early screening tests are available.

It is in this setting that emerging molecular analyses of blood specimens, so-called “liquid biopsies,” are poised to revolutionize cancer screening (5). Circulating cell-free DNA (cfDNA) in the blood consists of small fragments of DNA that are approximately 150 nucleotides in length. cfDNA is primarily derived from normal tissues, but a small fraction may be derived from tumor cells in individuals who have cancer. This circulating tumor DNA (ctDNA) may be identified by the presence of characteristic mutations in cancer genes or by variations in chromosome copy numbers (6). Recent studies have established the reliability of ctDNA genotyping for monitoring treatment response and identifying drug resistance mechanisms in patients with advanced cancer (7, 8). However, the much lower amount of ctDNA in the plasma of patients who have a localized tumor poses a challenge for early cancer screening, as does the absence of knowledge about which mutation to look for. Furthermore, some background mutations detectable in the blood may arise from nonmalignant proliferation of blood cells in older individuals, a phenomenon called clonal hematopoiesis of indeterminate potential (CHIP) (9). Importantly, cancer gene mutations alone are insufficient to identify the tissue of origin for a given cancer signal in the blood because similar mutations are present in multiple different cancers. Thus, a tissue-agnostic blood-based screening test has limited clinical utility, unless accompanied by insight into which organ should be investigated for follow-up…

There are a number of important caveats. The predictive value of any diagnostic test relies on the prevalence of the disease within the tested population. For instance, in testing apparently healthy individuals within the general population, the prevalence of all eight cancers can be conservatively estimated as 1% of people over age 64 (11). Hence, in this setting even a test that is 99% sensitive and 99% specific will yield a positive predictive value (PPV) of only 50% (half of all test positives will be a false-positive result). Similarly, a positive CancerSEEK test result would be predicted to have a PPV of 40 to 45% for a person having any of the eight different cancers (2). Although the model was not designed to screen for individual cancer types, breaking down the aggregate PPV into its individual component cancers would result in further reduction in PPV, particularly for rare cancers. Because PPVs improve with higher disease prevalence, application of any cancer screening test to subpopulations with increased genetic or environmental risk factors (for example, carriers of familial breast cancer susceptibility mutations, heavy smokers at risk for lung cancer, or patients with liver cirrhosis predisposed to hepatocellular carcinoma) would of course increase the likelihood of true-positive results.

A well-documented challenge in early cancer detection studies is that patient populations at increased risk for cancer may also have precancerous or inflammatory conditions resulting in baseline elevation of serum protein biomarkers, a confounding factor that is not well recapitulated in the healthy control population used to build the CancerSEEK test…

Undoubtedly, effective screening for early invasive cancers represents the best hope for reducing cancer mortality and morbidity. The conceptual advances and the practical feasibility of the CancerSEEK assay constitute an important milestone toward the application of early cancer detection. Most importantly, the ongoing development of cost-effective and accurate blood-based cancer screening strategies is poised to revolutionize clinical cancer care, bringing with it new emphasis on genetic and environmental risk stratification so as to tailor application of screening tests; minimally invasive imaging, biopsy, and molecular characterization of early tumors that are discovered and might be either indolent or invasive; and deployment of increasingly effective therapeutic options to stages of cancer for which they have curative potential. The vision of effective earlier cancer detection and intervention warrants validation in appropriate populations through large-scale clinical trials that are likely to radically change the way we diagnose and treat cancer.
Promising. Yet fraught with difficulty (pay particular attention to the "important caveats" paragraph).

Nonetheless, a priority research area in my view (in part, personally, because both of my late daughters presented at Stage IV).


ProPublica Patient Safety Community
Ran across this Facebook group (and joined) while searching out information about medical costs and pseudoscience / quack goods and services. Some of my prior blog riffs on patient safety issues are linked here.

Nobel Prize in medicine awarded to two cancer researchers for immune system breakthrough


On deck, "Data Science." Yet another fad?

Stay tuned. "Coding Boot Camps," anyone? More here.

More to come...

No comments:

Post a Comment